Leukemia, Myelogenous, ChronicNCT03421626
Clinical Evaluation of a Test for Monitoring Patients Diagnosed With Chronic Myeloid Leukemia (CML)
An observational study of Leukemia, Myelogenous, Chronic, run by Cepheid at 7 sites in United States.
Trial summary
The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States. Testing is performed on peripheral blood specimens provided by eligible enrolled patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Leukemia, Myelogenous, Chronic
- What is being tested?
- Xpert BCR-ABL Ultra
- Type of treatment
- Medical device
- How many people
- 266 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Nov 2017to 20 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females at least 18 years of age who were previously diagnosed with CML from primary care clinics.
Who may be able to join
- prospective specimens:
- Patient is at least 18 years of age
- Patient has provided documented informed consent as required by the reviewing IRB. Experimental Bill of Rights will also be documented for all subjects enrolled in applicable states.
- Patient has been diagnosed with CML.
- Patient consents to provide at least 12 mL of peripheral blood for study purposes
- frozen specimens:
- Specimen is from a subject diagnosed with CML
- Specimen meets the manufacturer's criteria to support testing by both diagnostic assays
Who cannot join
- prospective specimens:
- Patient is considered to be of insufficient health to supply the required volume of peripheral blood by his/her health care provider
- Patient has been previously enrolled
- frozen specimens: • Specimen previously enrolled
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
St. Alphonsus Regional Medical Center
Boise, Idaho, 83706
United Hospital Center
Bridgeport, West Virginia, 26330
WJB Dorn VA Medical Center
Columbia, South Carolina, 29209
Broward Oncology Associates
Fort Lauderdale, Florida, 33308
St. Mary's Medical Center
Huntington, West Virginia, 25702
Marshfield Clinic
Marshfield, Wisconsin, 54449
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems
The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States. Testing is performed on peripheral blood specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.
- Conditions
- Leukemia, Myelogenous, Chronic
- Being tested
- Xpert BCR-ABL Ultra
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert BCR-ABL UltraDevice
Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML
| Study group | Role | What they receive |
|---|---|---|
| Primary Enrollment | Initial enrollment of patients with history of CML Receives: Device: Xpert BCR-ABL Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method comparison to an on-market molecular diagnostic assay
Comparison of Xpert to an on-market test for the quantitation of BCR-ABL
Measured: Baseline = testing upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start8 Nov 2017
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Myelogenous, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cepheid
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421626
- Sponsor's protocol ID
- 231
- Status last verified
- Jan 2018
- First submitted
- 30 Jan 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Xpert BCR-ABL Ultra Assay on the GeneXpert Instrument Systems
- ClinicalTrials.gov ID
- NCT03421626
- Acronym / sponsor ID
- 231
- Conditions
- Leukemia, Myelogenous, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- CepheidIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to establish the performance of an assay that detects mRNA transcript levels in patients diagnosed with CML. The study is conducted at locations within the United States. Testing is performed on peripheral blood specimens provided by eligible enrolled patients. Results from this study will not be used for patient management decisions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Enrollment | – | Device: Xpert BCR-ABL UltraInitial enrollment of patients with history of CML |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females at least 18 years of age who were previously diagnosed with CML from primary care clinics.
Key inclusion criteria (8 listed)
- prospective specimens:
- frozen specimens:
Key exclusion criteria (4 listed)
- prospective specimens:
- frozen specimens: • Specimen previously enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert BCR-ABL UltraSemi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML | Device | Primary Enrollment |
Primary outcome
Method comparison to an on-market molecular diagnostic assay
Time frame: Baseline = testing upon enrollment
Comparison of Xpert to an on-market test for the quantitation of BCR-ABL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Myelogenous, Chronic, run by Cepheid at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Method comparison to an on-market molecular diagnostic assay (time frame: Baseline = testing upon enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.